(23 days)
The MaxTorque™ Screw System is intended to stabilize and aid in the repair of fractures, fusions, and osteotomies for small bones and bone fragments.
The MaxTorque™ Screw System is indicated for use in long and small bone fracture, fusion, and osteotomy fixation, which includes but is not limited to the following:
- Fractures of the tarsal and metatarsals
- Fractures of the olecranon, distal humerus
- Fractures of the radius and ulna
- Patellar fractures
- Distal tibia and pilon fractures
- Fractures of the fibula, medial malleolus, os calcis
- Tarso-metatarsal and metatarsal-phalangeal Arthrodesis
- Metatarsal and Phalangeal osteotomies
- Osteochondritis dissecans
- Ligament fixation
- Other small fragment, cancellous bone fractures and osteotomies
The submission is a modification to the MaxTorque™ Screw System to add additional screw styles and lengths. No modifications were made to the existing implants. The MaxTorque™ Screw System consists of screws of various diameters, lengths and thread configurations. The system also includes correspondingly sized washers, the use of which is optional.
The furnished information pertains to a conventional medical device (MaxTorque™ Screw System), not an AI/ML-driven device. As such, the typical acceptance criteria and study designs associated with AI/ML device performance (e.g., accuracy, sensitivity, specificity, reader studies, ground truth establishment by experts) are not applicable here.
This submission is for a modification to an existing screw system, adding new screw styles and lengths. The substantial equivalence is based on similarities in indications, design, and materials to previously cleared devices, supported by calculations and finite element analysis comparing the strength of the new and predicate devices.
Therefore, the specific information requested in the prompt, which is tailored for AI/ML-based medical devices, cannot be extracted from this document. The document focuses on demonstrating physical and mechanical equivalence for a hardware modification, not an algorithmic performance.
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510(k) SUMMARY
Submitter Information
MAY 3 1 2013
| MAY 31 | ||
|---|---|---|
| Submitter's Name: | OrthoHelix Surgical Designs, Inc. | |
| Address: | 1065 Medina Rd, Suite 500 | |
| Medina, Ohio 44256 | ||
| Telephone Number: | 330-869-9562 | |
| Fax Number: | 330-247-1598 | |
| Prepared By: | Brian Hockett, Liz Altenau | |
| Contact Person: | Derek Lewis | |
| Date Prepared: | 2/24/2013 | |
| Device Information | ||
| Trade Name: | MaxTorque™ Screw System | |
| Common Name: | Fixation Screws | |
| Classification Name: | Screw, Fixation, BoneWasher, Bolt Nut | |
| Device Classification: | Smooth or threaded metallic bone fixation fastenerClass II per 21 CFR 888.3040Panel: Orthopedic, Product Code: HWC | |
| Single/Multiple component metallic bone fixation appliances and accessories | ||
| Class II per 21 CFR 888.3030 | ||
| Panel: Orthopedic, Product Code: HTN | ||
| Material Composition: | Titanium Alloy | |
| Device Description: | The submission is a modification to the MaxTorque™ Screw System to addadditional screw styles and lengths. No modifications were made to theexisting implants. The MaxTorque™ Screw System consists of screws of variousdiameters, lengths and thread configurations. The system also includescorrespondingly sized washers, the use of which is optional. | |
| Intended Use: | The MaxTorque™ Screw System is intended to stabilize and aid in the repair offractures, fusions, and osteotomies for small bones and bone fragments. | |
| Substantial Equivalence: | The new MaxTorque™ Screws are substantially equivalent to the existingOrthoHelix MaxTorque™ Screw System (K082574 & K060428), the Asnis IIICannulated Screw System (K000080), the Asnis III Micro Cannulated ScrewSystem (K071092), the Smith and Nephew Cannulated Screws and WashersSystem (K111994) and the Synthes Headless Compression Screw System(K080943). The submission is a modification to the MaxTorque™ Screw Systemto add additional screw styles and lengths. Calculations and finite elementanalysis comparing the strength of the subject and predicate devices wereperformed and the results support substantial equivalence. Due to similaritiesin indications, design, and materials, no other testing was required. No newissues of safety and effectiveness have been raised. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
May 31, 2013
OrthoHelix Surgical Designs, Incorporated % Mr. Brian Hockett 1065 Medina Road, Suite 500 Medina, Ohio 44256
Re: K131324
Trade/Device Name: MaxTorque™ Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: May 21, 2013 Received: May 22, 2013 ·
Dear Mr. Hockett:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. Brian Hockett
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
For
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
ErinFDKeith
Mark Melkerson Director Division of Orthopedic Devices Office of Device Evaluation
Center-for-Devices-and-Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K131324
Device Name: MaxTorque™ Screw System
Indications for Use:
The MaxTorque™ Screw System is indicated for use in long and small bone fracture, fusion, and osteotomy fixation, which includes but is not limited to the following:
- Fractures of the tarsal and metatarsals -
- -Fractures of the olecranon, distal humerus
- Fractures of the radius and ulna ・
- Patellar fractures -
- Distal tibia and pilon fractures -
- Fractures of the fibula, medial malleolus, os calcis "
- -Tarso-metatarsal and metatarsal-phalangeal Arthrodesis
- Metatarsal and Phalangeal osteotomies l
- Osteochondritis dissecans
×
- Ligament fixation
Prescription Use _
(Part 21 CFR 801 Subpart D)
- Other small fragment, cancellous bone fractures and osteotomies
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elizabeth Frank -S
Page 1 of _1
Over-The-Counter-Use
(21 CFR 801 Subpart C)
Division of Orthopedic Devices
ﻠﻠﻠﻠ
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.